Thank you. I am very pleased to be here as part of your meeting—and grateful for a little respite from the cold and snow back home.

I appreciate the chance to be here today and your generous introduction and warm welcome. I have to say that in this role I am often a little uncertain about what kind of a welcome I will receive. This is not a job that always evokes warm feelings…though I have to say that I have been very heartened by the warm reception and welcomes I have received since my appointment as FDA Commissioner.

Beginning on the Hill as I made the rounds as part of the confirmation process, a place where certainly some FDA nominees have gotten frosty greetings, many Senators said the same thing to me: “Congratulations—and condolences. We have no idea why you’d want this job, but we’re glad you do!”

Senator Mikulski made the most memorable comment when she said, “You’re the daughter of a psychiatrist. Good. Because you’re going to need all the mental health you can get.” In fact, both my parents are psychiatrists, so I guess I am well-equipped…or, in fact, really crazy.

But I am really honored to be in this role, and very excited about the chance I have been given to work on issues that truly matter. In that regard, I am delighted for the opportunity to speak with all of you, the leaders of an industry that has come to play not only an important—but one of the most important—roles in the healthcare of Americans.

There are, of course, critical questions of policy and practice on all of our minds—questions of enforcement, biosimilars, user fees, and how my agency’s attitude and approach to your industry might differ from that of recent years. I hope to at least touch on all these matters before our time together is up.

But first, I would like to speak more fundamentally about how the Generics industry and the FDA have much in common—more than it may often seem—including a unique opportunity and burden in this new decade to help each other better help the public’s health.

I understand that when my colleague and Principal Deputy, Dr. Josh Sharfstein, spoke to your Policy gathering last year, he noted the accomplishments of your industry then but drew on words from the Spiderman comic series, to caution that “with great power comes great responsibility.”

Josh may be more knowledgeable than I in the realm of comics, but I am sophisticated enough to know that the genesis of that quote is a bit more complex…some attribute it to Franklin Roosevelt…and some take it back to the Bible. But whatever the source, the sentiment is true, and I think it is a useful concept for us to contemplate…together. For it holds true for both our organizations and I want to focus on that.

Let us, though, first begin with a simple question that, as busy leaders and pressured decision-makers, we don’t take the time to ponder often very often.

How did we get here?

Consider that 25 years ago for you, and about six times that for us, the Generics industry and the FDA were both nothing more than words on a piece of parchment in Washington. You were Public Law 98-417. We were Statute 12-387.

For us, those early years were rough. It was, believe it or not, the Great Emancipator, Abraham Lincoln himself, who created the Division of Chemistry that would evolve decades later into the Food and Drug Administration. But in 1862, that high-level support apparently didn’t translate into much.

Our first offices were, and I quote, “of a dark subterranean character,” where a “great dampness,” accented by “acid fumes,” prevailed. My early predecessor, whose salary was $1,500, had only resources enough to analyze a handful of grapes in his first study.

We’ve come a long way since those grapes. As the late Senator Edward Kennedy, one of our nation’s greatest champions of public health, put it, the FDA has become the most important health agency in America. Some raise their eyebrows at that characterization…but I wholeheartedly agree.

Consider that the FDA regulates more than 1 in every 5 dollars of consumer spending in this country—food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements, tobacco products, animal drugs, even some radiation-emitting products.

We are responsible for things people really care about and that matter for their health, safety and well-being. And even for things as mundane as the toothpaste we use in the morning, to that midnight snack we may sneak before bed—each of us is relying on the FDA, every day in so many ways. There’s no escaping that.

A new era of responsibility and authority for the FDA began in 1938 when President Franklin Roosevelt signed the Food, Drug, and Cosmetic Act into law. This wasn’t the occasion for which he wrote the words: “Great power involves great responsibility,” but the words apply.

And the words apply to all of you. Your industry did not begin in “dark subterranean” offices, but, much like us, you grew from a debate on Capitol Hill…and now, of course, into a thriving industry.

Today, it is widely recognized that generic drugs are just as safe and effective as their brand-name counterparts. Your industry commands more than 75 percent of America’s drug marketplace and saved consumers upwards of $750 billion over the past decade.

Clearly that means great power—and that, too, means great responsibility.

But responsibility can take many forms—to the bottom line, to our bosses and boards, to our investors. So let me clarify. While those are imperative responsibilities—ones we cannot and should not neglect—I am referring here to a distinctive responsibility that the FDA and the Generics Industry have uniquely in common.

We can remind ourselves of this responsibility when we ask not how we got here, as before, but WHY we got here.

The answer is simple. We were both created to better serve the public health. That is why Henry Waxman and Orrin Hatch worked tirelessly promoting your cause leading up to September 24, 1984, when the Hatch-Waxman Act creating the modern generic pharmaceutical industry was signed into law.

That is why another Roosevelt—Teddy—responded to Upton Sinclair’s exposé of the food industry at the turn of the last century and actually created the official Food and Drug Administration through the Pure Food and Drug Act, a law that vowed to protect the public against “misbranded, or poisonous or deleterious foods, drugs, medicines, and liquors.”

In other words, our duty to the public health is the necessary factor—the component without which we would not exist. And today, public health is the compass I try to use to steer the FDA through sometimes choppy waters.

Given my background as the New York City Health Commissioner, this is probably no surprise to you. But, partly for this reason, I was not the obvious pick for this position. In a gossipy town like Washington, it was actually humorous--though occasionally disturbing—that after being offered the job, accepting, going through vetting, but before my nomination was announced, I would read in the newspapers speculation about candidates for FDA Commissioner, and not see my name on the list.

But President Obama did not want to repeat the battles of past administrations—of nominating a pro-industry person who’s attacked by consumer groups, or nominating a pro-consumer person who’s attacked by industry groups.

I don’t think you have to be either/or to be pro-public health. And that’s what I am.

So what does this public health perspective really mean? The Institute of Medicine has defined the mission of public health as "fulfilling society's interest in assuring the conditions in which people can be healthy."

To be healthy, people need access to a safe and nutritious food supply and to the safest, most effective medical products possible. The FDA's role is to support this access and, in doing so, to promote health, prevent illness and prolong life.

Nearly two decades ago, when I first began my career in public health and accepted the position of New York City Health Commissioner, my great-aunt Winnie was baffled and upset by my decision. She complained to my father that she just couldn't understand why I would give up the opportunity to be a "real doctor."

My father tried to offer some consolation by telling her that I would still be a real doctor, but that instead of having one patient at a time, I would simply have eight million. Aunt Winnie didn’t buy it—but I did. And now I guess I have more than 300 million patients.

But as you know, the public isn’t so sure we are doing a very good job protecting our so-called “patients”... and no doubt that includes some of you. For much of our history, the FDA has been very popular. We used to rank at the top of government agencies in public opinion polls—second only to the National Park Service. Now we’re down in the 30s—and sad to say, just ahead of the Internal Revenue Service.

When your job is protecting the people, and the people like you as much as they like the tax collector, they’re sending a message that it’s time to change.

So that is exactly what we’re doing. We’re putting public health first, and we’re acting in a more agile and assertive way. Let me give you some examples.

In late 2008 there was an outbreak of salmonella related to peanuts. In fact, contaminated peanuts were detected by officials in Canada and returned to the US weeks before we knew of anyone getting sick. The FDA appropriately rejected the product at the border, calling it “unfit for food.” But the agency did not trace the peanuts back to the plant. That happened only after people started getting sick.

The FDA reacted as a regulatory agency, not as a public health agency. The Agency made sure to meet a very strict regulatory timeframe and mode of action—which means that you wait for the epidemiology from the CDC, you make sure you’re certain of everything, and then you go out with your action and your announcement.

Tragically, this proved to be one of the worst outbreaks. Eight people lost their lives, and nearly 20,000 got sick.

When President Obama came into office, the peanut outbreak was still resolving. He was first personally—and then as President—struck by just how important confidence in safety…in the products on the shelves and in our homes….really is. When he announced my appointment, he spoke to these issues and called for action.

The following month, in April, there was, in fact, another problem with nuts, this time pistachios. Kraft Foods alerted us that they had found salmonella in pistachios purchased from a company in California.

This time the agency did respond differently. We inspected the facility and found serious contamination. All this began before there were any confirmed cases of illness. Product was held, and we quickly put out a warning to consumers not to eat pistachios, but not yet to throw anything out.

We soon found the source of the contamination and narrowed the scope of our advice to the public. And we quickly helped the industry create a website that pointed consumers to products that were definitively not involved in the recall and were safe to eat.

Confidence was rapidly restored in both the product and the industry. The public did not panic, lives were not lost…nor were jobs. There were no huge costs to the industry. And this was certainly different than with peanuts. I think this was clear progress.

When, in another example of the new FDA, we issued a general warning to consumers about fraudulent products that claimed to diagnose, prevent, treat, or cure the H1N1 virus—and issued more than 5 dozen warning letters to offending websites—a trade press op-ed said, “FDA is taking extraordinary measures to protect the public from illegal H1N1 products…”

In the future, I hope FDA enforcement will be neither surprising nor extraordinary.

But my measure of success is not how many enforcement actions we've taken. Our goal is compliance, and enforcement is a path to compliance. We want to work with companies to help them comply with standards…and the majority do. But if companies do not, they need to have a realistic expectation that if they are crossing the line, we will act.

It’s a change of approach. If FDA is too slow to recognize and respond to serious safety problems, then people are going to suffer unnecessarily…or even die preventable deaths. And our credibility will suffer…and it will deserve to suffer … and so will the credibility of industry.

We’re going to act to protect the public. And in doing so, we’ll improve trust and confidence in our work and that of the industry we regulate.

As the FDA and the generics industry recognize our shared mission, I believe there are a number of key ways we can—and must-- in fact, work together to more effectively respond to the public health threats and opportunities of our changing world.

First, I believe the FDA—and the generics industry—must try to better identify and prevent problems—to ensure quality—before problems occur. This is a basic tenet of public health, and a principle that must drive all of our work at FDA.

The principle of prevention is at the core of our Quality by Design program, which aims to build quality into each stage of the production process. We are asking not just how to fix problems….but how they can actually be prevented.

And we are reorienting our inspectors to focus on key measures for prevention, not just evidence of current problems.

But the world has gotten decidedly more complicated and so too have our jobs. We are feeling the challenge of globalization as I’m sure you are as well. When President Roosevelt created the modern FDA back in 1938, life was simpler. There were fewer facilities and many fewer imports. We were able to inspect more regularly—and with more certainty.

Today, FDA-regulated products are imported from more than 150 countries, with more than 130,000 importers and more than 300,000 foreign facilities.

The number of foreign registered drug manufacturers more than tripled over the past nine years. The number of drug products created at foreign sites has more than doubled since 2001. And the largest increase in drug manufacturing, as I suspect you know, has been in China and India, where there has been a huge ramp-up in FDA-registered drug manufacturers.

More countries than ever before are now part of the global supply chain, which means more factors and more barriers—barriers of language, geography, time, culture, facility information, and product history—that are largely out of our control.

Simultaneously, the supply chain from manufacturer to consumer has become more and more complex … involving a web of re-packagers and redistributors… and making oversight significantly more difficult.

This all adds up to an enormous task for the FDA…and we know that there are very real concerns. We all remember contaminated heparin vividly, and there have been many other problems as well. I was just reading a new report on the threat of counterfeit drugs which is growing worldwide.

Clearly we need a new paradigm for the 21st century.

We can never inspect our way to safety…that would mean hiring an army of tens, perhaps hundreds, of thousands of people to inspect foreign facilities and open every crate as it comes across the border. That simply won’t work.

Instead, it means building up a worldwide network of oversight, working closely with other national governments and regulatory authorities, working with international organizations and others to harmonize standards and approaches, building regulatory capacity in other countries, developing third party certification systems, and sharing the responsibility of inspections and the information that comes from them.

But it also means—and I want to be clear here—that industry must also bear responsibility for the safety of the products in their supply chain, and not rely on the FDA to show up and find a problem. There are no free lunches, all parties must play a role—a proactive one—thinking both locally and globally to anticipate problems before even one human being is needlessly harmed.

The task of securing the international supply chain is a huge endeavor that will require fundamental and systemic change in the way we, and all of our trading partners, think about product safety.

It is a responsibility we share, and it’s what we must do.

Second, we must do a better job developing the science that is the foundation of effective regulation.

When I started medical school, I was told that—with the advent of drugs and vaccines—the era of infectious diseases was basically over, and that the future of medicine was chronic disease. That was in the late 70s. Then we began to see the emergence of these strange cases of immune deficiency, mainly in previously healthy young men; nobody knew what the cause was and nobody even knew what to call it. I remember it was called GRID and 4H Syndrome…and then it was AIDS.

By the time I did my residency in New York City, I was taking care of a lot of AIDS patients. But there was nothing we could give them. There were no drugs available, only supportive care.

Later, I worked with Tony Fauci as assistant director of the National Institute of Allergy and Infectious Diseases. At that point in the AIDS epidemic, the great push was getting as many people as possible into the clinical trials, so they’d have at least some chance for treatment. But there were many people that were dying of AIDS that didn't qualify for the clinical trials and had no way to get drugs.

I was dealing every day with desperate people who wanted to live and had no hope.

Those were my early years in medicine, and they made me a passionate believer in the urgency of getting medical products to those who need them, and that success depends on teamwork; on the collaboration of scientists, pharmaceutical companies, advocates, and also the underappreciated midwife of drug development and approval: regulatory science.

Regulatory science is the science needed to evaluate, ensure and monitor a product’s safety, effectiveness, potency, quality and performance. We need to advance this science to include new tools, methods, assays, standards, and models that will help speed the development, review, and approval of medical products.

Regulatory science may not be as sexy as discovery science…but it is really important and it really matters if we want to get products to people.

Let’s start with biosimilars. As you know, there are a lot of concerns. How will we regulate these? Which framework will we use? These are important questions because patients want and need more access to these products—and, of course, I know how much promise they hold for your industry. Understandably, you’re eager for answers.

First, we must develop a robust biosimilar approval pathway, which is more than what any short-term political patch can provide. After all, biosimilars raise questions for regulators that are far more complex than those posed by traditional generics.

For particular products, will we need clinical studies beyond bioequivalence? Is interchangeability possible? How will the approval process differ from the Biologic License Applications process?

We will address these questions as we work together over the coming months, which I look forward to, but I can say now that there will not be a ‘one-size-fits-all’ approach. There will, rather, be a science-driven, case-by-case decision-making process rooted in the regulatory studies that I would encourage your industry to support—as the FDA will—at this crucial time. The FDA can advance some of the science, but we can’t do it all.

That may account for emerging generics, but what about the many existing generics? Even as we try our best to clarify to consumers that generics are safe, effective, and equivalent—and shortly after I became Commissioner, we revamped our website to dispel the myths about generics that persist—your industry can also work to better assess outcomes and act upon your findings.

Just as the FDA is beginning again to act aggressively and agilely in response to any credible report of impending problems, I ask that you, too, take public concerns seriously and rigorously investigate any potential therapeutic inequivalence. This too is a component of regulatory science.

I was encouraged to learn that some of you are, in fact, starting to support such studies examining these concerns. I believe you are making the right decision—for your bottom line, for your reputation, and above all, for your consumers.

Finally, let me mention that as we all know, no one benefits from a pending-application queue that will soon hit the 2,000 mark. This is simply unacceptable. Uncertainty and delays are costly to consumers, costly to you—and hurtful to the public. But the unprecedented spike in generics applications has simply outstripped our capacity to properly review, which must remain our foremost focus.

The solution lies in resources.

We have already begun to use the $10 million that Congress allotted to our agency to hire 50 additional scientists to address the generics-application backlog. But without action from your industry, too—without your support for a fair system of user fees—we simply cannot achieve for the public what we otherwise could. I know we have an essential part to play, too, in providing your industry with meaningful benchmarks...and in performing to those goals.

We very much want to work with you to see generic drug user fees enacted this year. Adequate and reasonable fees will be key to both more rapid review and to better surveillance. The merits of the former, I know are obvious to everyone in this room. But as I was just discussing, a robust inspectional presence is also critical to consumer confidence in safe and high-quality products.

And with the industry becoming ever more global, the continuing threat of intentional economic adulteration, and the increasing complexity of supply chains, we face tremendous challenges in our efforts to prevent or detect problems early – and user fees can assist us in meeting those challenges.

So I do hope we can return to the negotiating table soon.

Third, and finally, we must begin to better assess outcomes—to focus on quality after, not only before, the approval and release of products.

We are in the beginning of a new era for drug safety where protecting public health means that the FDA’s responsibility doesn’t end when we grant a product pre-market approval; that is merely the first check point in assuring safety.

Our responsibility extends for the entire time those products remain on the market. This life-cycle approach—as codified in the 2007 FDA Amendments Act —is a critical advance in public health protection. We are developing and honing the range of tools necessary to meet this important responsibility.

Post-marketing surveillance is key, but so is the ability of FDA require label changes to reflect new safety information, or to develop a Risk Evaluation and Mitigation Strategy, or REMS, for a particular drug. Medication guides, targeted outreach to health care professionals and pharmacists, or maybe even restrictions on who may prescribe the drug and under what circumstances an at-risk patient may take the drug is also important.

Last fall, we launched a Safe Use Initiative to encourage—in a broader way--that medications be used safely—meaning not accidentally ingested or overdosed… not given to patients who will not tolerate them… and not used inappropriately by patients at home.
Through this effort, we have partnered with a wide range of allies—from hospitals to health plans to pharmacies—and we will monitor our progress closely to be sure we are on the right track.

Just yesterday, FDA announced a new approach to confusion over the naming of over-the-counter drugs. We are discouraging companies from labeling different active ingredients with the same names – this confuses consumers and leads to avoidable, serious adverse events. Yesterday, with the support of FDA, one major company – the maker of Maalox -- is agreeing to rename some of its products to avoid confusion and better protect patients.

The generic industry is a critically important partner in our effort to encourage the safe use of medications. I know Dr. Sharfstein has challenged you to consider, for example, the serious problem of acetaminophen overdose. Many people take generic pain medication without recognizing that acetaminophen is a component. Then they take acetaminophen separately, and as a result, they may suffer serious liver injury.

These are significant concerns. If companies do not recognize that their business practices put patients at risk, and take action, then FDA will be forced to do so.

Together, we carry the sacred burden of safety. We must take this responsibility seriously.

So as I close, I want to reflect back on something my old boss President Clinton said back in 2000, when he spoke at the United Nations for the last time, to the largest-ever gathering of heads of state. He closed his remarks with these powerful words: “The leaders here assembled,” he said, “can rewrite human history in the new millennium. But we must believe the simple things—that everywhere in every land, people in every nation, matter. Everyone counts, everyone has a role to play, and we all do better when we help each other.”
I know that President Clinton was talking about a world far afield from the FDA or the generics industry at the time. But this morning, his message could not apply more.

The leaders here assembled can, and will, do better when we embrace the fact that everything—every factory, every ingredient, every product, every process, every consumer, every application—in fact matters.

And that a stronger FDA, one the public trusts as much as it once did, will translate into greater public confidence in your industry as providers of the safe, effective, equivalent, and affordable medicine on which so many have come to rely. In short, “we all do better when we help other.”

In that spirit above all, I look forward to our discussion in the coming days, weeks, and months. But as President Lincoln, the patron saint of that dark, subterranean FDA precursor, once said, let us “leave nothing for tomorrow which can be done today.”